deltatrials
Recruiting OBSERVATIONAL NCT02578810

PIERS and BIS, sFIT:PIGF, Adrenomedullin (BIS2)

Sensitivity and Specificity of Bispectral Index (BIS) EEG Parameter, sFIT (Soluble FMS Tyrosine Kinase): PIGF (Placental Growth Factor) Ratio, Adrenomedullin for Grading Preeclampsia Integrated Estimate Risk Score (PIERS)

Sponsor: Suez Canal University

Conditions Eclampsia
Updated 16 times since 2017 Last updated: Apr 22, 2026 Started: Oct 1, 2016 Primary completion: Dec 1, 2030 Completion: Dec 1, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Eclampsia, this trial is actively recruiting participants. The trial is conducted by Suez Canal University and has accumulated 16 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Background: Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.2 To quantitatively asses electroencephalography (EEG) mental involvement in Pre-eclampsia is still time consuming and not always readily available. PIERS was developed and internally validate as a pre-eclampsia outcome prediction model- (Preeclampsia Integrated Estimate of RiSk) model.3 The purpose of our study was to evaluate the discriminative power of the Bispectral Index (BIS), biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio,4 and adrenomedullin mortality risk stratifier,5 to classify the degree and progression of pre-eclampsia. Methods: In 24 patients with Eclampsia or pre-eclampsia investigators will use an artefact-free 20-min mean BIS value, as well as biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio and adrenomedullin mortality risk stratifier to classify the degree of pre-eclampsia correlated the PIERS Pre-eclampsia risk assessment PIERS percentage (http://piers.cfri.ca/PIERSCalculatorH.aspx) will be calculated from patients' clinical and laboratory findings documented in their charts, compared with 24 pregnant patients...

Background: Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.2 To quantitatively asses electroencephalography (EEG) mental involvement in Pre-eclampsia is still time consuming and not always readily available. PIERS was developed and internally validate as a pre-eclampsia outcome prediction model- (Preeclampsia Integrated Estimate of RiSk) model.3 The purpose of our study was to evaluate the discriminative power of the Bispectral Index (BIS), biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio,4 and adrenomedullin mortality risk stratifier,5 to classify the degree and progression of pre-eclampsia.

Methods: In 24 patients with Eclampsia or pre-eclampsia investigators will use an artefact-free 20-min mean BIS value, as well as biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio and adrenomedullin mortality risk stratifier to classify the degree of pre-eclampsia correlated the PIERS Pre-eclampsia risk assessment PIERS percentage (http://piers.cfri.ca/PIERSCalculatorH.aspx) will be calculated from patients' clinical and laboratory findings documented in their charts, compared with 24 pregnant patients without Eclampsia or pre-eclampsia.

Status Flow

~Jan 2017 – ~Sep 2017 · 8 months · monthly snapshot~Sep 2017 – ~Apr 2018 · 7 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Jun 2019 · 8 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Nov 2020 · 16 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Nov 2022 · 13 months · monthly snapshot~Nov 2022 – ~Dec 2023 · 13 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2026 · 17 months · monthly snapshot~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotApr 28, 2026 – present · 2 months · daily API

Change History

16 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Recruiting

    Status: UnknownRecruiting

  2. Feb 2026 — Apr 2026 [monthly]

    Unknown

    Status: RecruitingUnknown

  3. Sep 2024 — Feb 2026 [monthly]

    Recruiting

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting

  5. Dec 2023 — Jul 2024 [monthly]

    Recruiting

Show 11 earlier versions
  1. Nov 2022 — Dec 2023 [monthly]

    Recruiting

  2. Oct 2021 — Nov 2022 [monthly]

    Recruiting

  3. Jan 2021 — Oct 2021 [monthly]

    Recruiting

  4. Nov 2020 — Jan 2021 [monthly]

    Recruiting

  5. Jul 2019 — Nov 2020 [monthly]

    Recruiting

  6. Jun 2019 — Jul 2019 [monthly]

    Recruiting

  7. Oct 2018 — Jun 2019 [monthly]

    Recruiting

  8. Jun 2018 — Oct 2018 [monthly]

    Recruiting

  9. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NANone

  10. Sep 2017 — Apr 2018 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  11. Jan 2017 — Sep 2017 [monthly]

    Not Yet Recruiting NA

    First recorded

Oct 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.

Contact Information

Sponsor contact:
  • Suez Canal University
  • University of Malaya
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations